Analyst, QC Microbiology (2-2-3, 1800-0600)

Fujifilm•Holly Springs, NC

33d

About The Position

The QC Analyst is responsible for the key operational aspects of the QC Microbiology laboratory. Incumbent will perform microbial testing of all in -process drug substance, drug product, EM/UM, and raw materials samples. Incumbent will be responsible for all associated activities associated with this testing in accordance with written procedures. This position primarily works under minimal supervision as needed. This position will initially be involved in the commissioning activities involved in the construction of a new Biopharmaceutical manufacturing facility and laboratory. Flexibility in job roles and assignments will be required. This may include writing or assisting with document preparation and review, managing project timelines, conducting qualification and validation protocols, and assisting management with training and on-boarding of new staff as needed and in addition to regular work duties and assignments. Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Requirements

BA/BS in scientific discipline
0-2 years of basic GLP laboratory experience
Understanding of GMP, GLP, GDP requirements
Knowledgeable in basic sciences and Microbiology laboratory methods and procedures
Basic LIMS training
Ability to discern audible cues.
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
Ability to ascend or descend ladders, scaffolding, ramps, etc
Ability to stand for prolonged periods of time up to 60 minutes.
Ability to conduct activities using repetitive motions that include writs, hands and/or fingers.
Ability to sit for prolonged periods of time up to 60 minutes.
Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions.
Will work in small and/or enclosed spaces.
Will work in heights greater than 4 feet.

Nice To Haves

BS within Microbiology, Chemistry, Biochemistry, Biology
2+ years of Intermediate experience in a GMP QC Microbiology Laboratory, knowledge of all compendial test methods (Bioburden, Endotoxin, sterility testing) preferred
Ability to troubleshoot and maintain laboratory equipment and instrumentation
Experience with microbial ID systems (MALDI, MicroSeq)
Intermediate LIMS training
Knowledge or training of FDA regulations (cGMP, cGLP, cGDP)
Trackwise System training
Lean / 6S training

Responsibilities

Collects samples for Environmental monitoring (EM) and Utilities monitoring (UM). Responsible for all sample collection and logistics as needed.
Coordinates testing materials and supplies needed for testing
Performs Basic Microbiology laboratory testing following standard procedures for all samples, including but not limited to all in-process samples, raw materials, EM and utilities samples for Bioburden, Endotoxin, plate reading, and microbial identification
Performs sterility testing, isolator qualification and routine operations and maintenance
Sample and data entry into LIMS system
Reviews general lab testing results
Troubleshoots routine assays
General laboratory support and laboratory maintenance in a cGMP laboratory including maintaining laboratory supplies needed for operations, maintenance of analytical instruments, purchasing and receiving of laboratory supplies (media, kits, etc.)
Ensures CAPAs are being followed in the laboratory areas
Notifies management and assists with the initiation of events (such as deviations) in the quality systems
Assists with projects as assigned
Works 12-hour shift on 2-2-3 cadence, 0600-1800
Performs other duties as assigned